EU → North America Device Access

Calzificio Pinelli Srl

IT-MF-000005917 · Italy · Castel Goffredo (Mn)

Calzificio Pinelli Srl is registered in the European database on medical devices as a manufacturer, with 3 716 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa3 716

Devices declared under this manufacturer

Showing 12 of 3 716 declared devices.

Catalogue references include 0127A4, 013130, 0131A0, 0301A5, 0318A0, 0354A5.

European nomenclature codes declared: M030499.

United States market access

FDA establishment registerRegistered with FDA
Matched entryCALZIFICIO PINELLI SRL (IT) · FDA 3007084481
Devices in EUDAMED3 716
Country of registrationItaly

Device-level evidence

Devices with a numeric GTIN3 716
Found in the U.S. device database3 602
Share96.9 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: United States only. Calzificio Pinelli Srl is registered in the United States but was not found in the Canadian register.

Other manufacturers in Italy

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